NCT06814132CompletedPhase 1
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease
Source: ClinicalTrials.gov · Last updated 23 Oct 2025
Brief summary (registry, in English)
The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 3 Feb 2025
- Start date
- 7 Apr 2025
- Primary completion date
- 4 Oct 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT06814132
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 7 Apr 2025 to the primary completion date, 4 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had a renal transplant
- Has required frequent emergent HD (≥ 3) within a year prior to the first dosing
- Has had a functioning renal transplant within the past 2 years
Other illness
- Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
- Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
- Has a history of cancer (malignancy)
- Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Participants with Severe RI (Group 1):
Other
- All Participants:
- Has a history or presence of renal artery stenosis
- Has ESRD requiring HD
- Participants with ESRD (Group 2):
- Has a history or presence of renal artery stenosis.
Who the study is looking for
- All Participants
- Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing
- Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening visit
- Participants with severe renal impairment (RI) (Group 1):
- Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Participants with end-stage renal disease (ESRD) (Group 2):
- Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit
- Healthy Control Participants (Group 3):
- Has normal renal function
Age in the registry: 18 years to 85 years · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research by Design ( Site 0001) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Orlando Clinical Research Center ( Site 0002) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.